Significance and Use
4.1 This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic femoral hip prostheses subject to cyclic loading for large numbers of cycles.
4.2 The loading of femoral hip designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic femoral hip designs, when tested under similar conditions.
4.3 In order for fatigue data on femoral hip prostheses to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.
1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
E1150 Definitions of Terms Relating to Fatigue
ISOâ7206– Determination of Endurance Properties of Stemmed Femoral Components with Application of Torsion
arthroplasty; femoral hip prostheses; orthopedic medical devices; proximal fixation; total hip arthroplasty;
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
ASTM International is a member of CrossRef.
Citing ASTM Standards
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